Job Description
POSITION SUMMARY:
Responsible for QA related projects that vary in scope, complexity and size. Oversee QC laboratory data to ensure compliance with current GMPs.
PRINCIPAL DUTIES:
- Review laboratory data and audit to ensure accuracy.
- Maintain QA records (i.e. logbooks, equipment records, specifications, procedures).
- Review procedures, SOPs, instrument IQ / OQ protocols and reports, method validation and implementation protocols and reports, and other documentation for regulatory compliance.
- Coordinate responses to internal, customer and regulatory inspection observations.
- Coordinate and perform internal audits.
- Monitor inspection trends for impact on laboratory operations.
- Ensure the proper storage of controlled documentation like archives and back-ups.
- Maintain documentation, certifications, and training records.
- Establish, institute and provide new employee orientation for QA related activities.
REQUIREMENTS:
- Bachelor's Degree in Chemistry, Biology, or Biochemistry and two (2) to five (5) years of experience in the same or closely related cGMP environment.
- Demonstrated competence in QA related activities through education and experience.
- Demonstrated ability to work under minimum supervision; exhibit leadership skills to coordinate personnel and projects on various levels.
- Excellent oral and written communication skills are required.
- Experience in sterile product manufacturing is a must.
Company Description
PYRAMID Laboratories, Inc. (PYRAMID) is a rapidly growing Contract Aseptic Manufacturer and Analytical Service provider in the pharmaceutical industry.
Our mission is to provide clients with Top Quality reliable services assuring that their critically important parenteral products reach patients
in need. PYRAMID offers a wide array of services for all phases of drug development, including:
Aseptic Filling
Formulation & Process Development
Lyophilized Product Formulation & Cycle Development
Product Process Validation
Clinical and Commercial Vial & Syringe fill / finish
Clinical and Commercial Lyophilization batches
Labeling & Packaging
Analytical Quality Control Laboratory Services
Analytical Method Development & Validation
API & Drug Product Stability Studies
Please visit: www.pyramidlabs.com for more information.